Telerehabilitation in Cancer Patients: Optimization of Prehabilitation and Rehabilitation Following Colorectal Resection

NCT06593678 | Recruiting

• 1 other identifier: UZ-USJ-CCR
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

This study, titled: Telerehabilitation in Oncology Patients: Optimization of Prehabilitation and Rehabilitation Post-Colorectal Resection. Is a randomized clinical trial conducted at the Royo Villanova Hospital in Zaragoza, Spain. It aims to evaluate the effectiveness of a tele-rehabilitation program in enhancing functional capacity and quality of life for patients undergoing colorectal cancer surgery. Colorectal cancer (CRC) is a highly prevalent malignant tumor that significantly impacts global health and patients\' quality of life, particularly after surgery. Prehabilitation and postoperative rehabilitation are crucial for recovery, and telerehabilitation offers a promising alternative to improve outcomes in CRC patients.

Conditions

Colorectal Cancer; Telerehabilitation; Physical Therapy

Keywords

Colorectal Cancer; Telerehabilitation; Physical Therapy; Functional Recovery; Multimodal program; Quality of life; Psychosocial factors

Outcome Measures

Primary Outcomes (1)

• Functional Capacity - Six Minute Walking Test (6MWT)

  The primary outcome is the improvement in functional capacity, which will be evaluated using the Six Minute Walking Test (6MWT). This test measures the maximum distance a patient can walk in six minutes along a flat, straight corridor under controlled conditions. The results provide an objective assessment of the patient\'s functional capacity, reflecting their ability to perform daily activities and their level of postoperative recovery.

  Functional capacity will be assessed at four time points: pre-intervention (T1), the day before surgery (T2), 21 days post-surgery (T3), and 50 days post-surgery (T4).

Secondary Outcomes (13)

• Pulmonary Capacity - Spirometry Assessments

  Measured at pre-intervention (T1), the day before surgery (T2), 21 days post-surgery (T3), and 50 days post-surgery (T4).

• Upper Limb Muscle Strength - Hand Grip Test

  Measured at pre-intervention (T1), the day before surgery (T2), 21 days post-surgery (T3), and 50 days post-surgery (T4).

• Lower Limb Muscle Strength - Sit to Stand Test

  Measured at pre-intervention (T1), the day before surgery (T2), 21 days post-surgery (T3), and 50 days post-surgery (T4).

• Body Composition - Bioelectrical Impedance Analysis and Waist-to-Hip Ratio

  Measured at pre-intervention (T1), the day before surgery (T2), 21 days post-surgery (T3), and 50 days post-surgery (T4).

• Postoperative Complications - Comprehensive Complication Index (CCI)

  Evaluated 3 months post-surgery (T5).

Study Arms (2)

Intervention Group. Asynchronous telerehabilitation

EXPERIMENTAL

Receive a home-based rehabilitation program via an asynchronous digital telerehabilitation platform.

Other: Telerehabilitation Program

Control Group. Booklet-based rehabilitation

ACTIVE COMPARATOR

Receive a booklet-based rehabilitation program at home through a detailed printed guide (explanatory booklet).

Other: Booklet-based rehabilitation program

Interventions

Telerehabilitation Program OTHER

Participants in the intervention group will receive a home-based rehabilitation program delivered via an asynchronous digital telerehabilitation platform. The multimodal program is accessible at online platform and it is composed for therapeutic exercises, including aerobic and strength training exercises, aimed at improving functional capacity and quality of life before and after colorectal cancer surgery.

Also known as: Asynchronous Digital Rehabilitation

Intervention Group. Asynchronous telerehabilitation

Booklet-based rehabilitation program OTHER

Participants in the control group will receive a booklet-based rehabilitation program at home, provided through a detailed printed guide (explanatory booklet). This guide includes instructions in pictures and text for the multimodal program. It is composed for therapeutic exercises, including aerobic and strength training exercises, aimed at improving functional capacity and quality of life before and after colorectal cancer surgery.

Also known as: Printed Guide Rehabilitation

Control Group. Booklet-based rehabilitation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18 and 80 years.
• Participants who understand Spanish.
• Patients scheduled for colorectal cancer surgery at Royo Villanova Hospital, Zaragoza, Spain.
• Patients attending the first consultation in the General and Digestive Surgery Section under the supervision of Dr. Blas, head of surgery at Royo Villanova Hospital, Zaragoza, Spain.
• Participants with functional independence that allows them to perform walking and pulmonary function tests.
• Patients with a preoperative assessment score of I, II, or III on the American Society of Anesthesiologists (ASA) scale.
• Participants who agree to participate and sign the informed consent form.

You may not qualify if:

• Patients older than 80 years.
• Patients with a preoperative ASA score of IV.
• Patients with any injury, pathology, or inflammatory processes that make it impossible to practice exercise.
• Patients with central and/or peripheral neurological diseases that prevent them from following the rehabilitation program.
• Patients with unstable cardiac comorbidities such as arrhythmias, high blood pressure, angina pectoris, or other conditions that contraindicate moderate-intensity training.
• Patients diagnosed with a psychiatric disorder as confirmed by a psychiatrist.
• Patients without access to mobile internet or a computer with internet at home.
• Patients who score ≤ 24 on the Mini-Mental State Examination (MMSE).
• Individuals who are unable to follow oral and written instructions in Spanish.
• Patients who refuse to participate in the study or who have not signed the informed consent form.

Sponsors & Collaborators

• Instituto de Investigación Sanitaria Aragón: lead
• Universidad de Zaragoza: collaborator
• Universidad San Jorge: collaborator
• Hospital Royo Villanova de Zaragoza: collaborator

Study Sites (1)

Hospital Royo Villanova

Zaragoza, Zaragoza, 50015, Spain

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Sandra Calvo, PhD

  Universidad de Zaragoza

  PRINCIPAL INVESTIGATOR

Central Study Contacts

José Manuel Burgos Bragado, MSc

CONTACT

+34 646 207 142; jmburgos@usj.es

Sandra Calvo, PhD

CONTACT

+34 661 833 194; sandracalvo@unizar.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Single Blind (Outcomes Assessor)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Model Details: Prospective, sigle-blind randomized clinical trial with two parallel interventions

Study Record Dates

• First Submitted: August 29, 2024
• First Posted: September 19, 2024
• Study Start: August 30, 2024
• Primary Completion: April 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: September 19, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)